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LPC Snapshot: Umbilical Cord Blood Banking - The Current and Evolving State

  

Rajdeep Das, MD, PhD, FIBMS 
Director of Histocompatibility and Immunogenetics and Immunotherapy Lab
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States

Over the years, various models of cord blood banks have been developed to store and manage umbilical cord blood (UCB) for potential future use. The two most commonly known options are public and private/family banking. Public banks play a critical role in providing a diverse and accessible resource for patients in need of transplants, while private/family banks offer a form of biological insurance for families who choose to store their child's cord blood for potential future use. Public cord blood banking is supported by major health organizations like the American Academy of Pediatrics and the American College of Obstetricians and Gynecologists. Table 1 shows some key differences between public and private cord blood banks.

Table 1

Public Umbilical Cord Blood Banks

Private/Family Cord Blood Banks

Nature

Non-profit, often funded by federal or private philanthropic sources

Generally for-profit companies

Purpose

Collects and stores umbilical cord blood for public use

Stores umbilical cord blood for personal use by the donor's family

Cost

Free for donors

Charges fees for collection and ongoing storage. There is an initial collection and processing fee, along with annual storage fees.

Use

Available for all patients needing transplants (allogeneic)

Intended for autologous or family-directed use, though scientific support for autologous use is limited

Donation

Parents donate their baby's cord blood to a public bank, where it is made available to anyone in need of a transplant

Generally, parents pay to store their baby's cord blood for potential future use by their family

Regulation

Must meet FDA standards for donor screening and infectious disease testing.

Must comply with FDA tissue-handling requirements but less stringent compared to public banks

Quality Control

Units must meet stringent standards; otherwise, they are discarded.

May not always meet the same standards as public banks, potentially reducing usefulness.

Benefits

Promotes a communal resource for transplants.

Increases availability of matched units, especially for minority populations.

Provides a sense of security for families with a known medical condition that might benefit from cord blood transplantation.

Marketed as "biological insurance" against future diseases, although this is not strongly supported by scientific evidence.

Issues with Public Cord Blood Banking:

While public cord blood banking is endorsed by some prominent medical societies, it is not devoid of issues. Some of the common challenges with public cord blood banking are:

Donor Variety: Finding a suitable match in the public inventory can be challenging, especially for individuals of mixed ethnicities and races. Research indicates that while Caucasians without a matched, related donor have a 70% chance of finding a match, individuals of other or mixed ethnicities have only a 10% chance (1). Private banking ensures that a child’s umbilical stem cells are exclusively available to the family, providing a guaranteed match for the child and a high likelihood of compatibility for siblings and other family members.

Collection Ineligibility: Public cord blood donation criteria can be stringent, with many donations falling short of the required cell count, blood volume, or other criteria. Maternal health and other factors can also impact donation success, leading to nearly 70% of cord blood donations being discarded (2). Private storage allows families more flexibility in storing and using their cord blood and tissue.

Unequal Standards: Standards for cord blood banking vary, with public banks required to obtain the U.S. FDA biologics license application (BLA) approval or be subject to an investigational new drug (IND) application. However, the time and cost to procure licensure mean some banks operate while still in process. Disparities in factors like transit time, storage temperature, and the quality of collected units can affect the viability of public banked units. Additionally, fewer than 200 hospitals in the U.S. participate in public cord blood banking, leading to significant amounts of umbilical cord stem cells being discarded.

Strictly Cord Blood: Most private banks offer the option to collect and store both cord blood and cord tissue, while public banks typically do not process and store cord tissue. This limits future treatment possibilities, as mesenchymal stem cells (MSCs) found in cord tissue are being studied in clinical trials for numerous conditions, including cerebral palsy, multiple sclerosis, diabetes, cardiovascular diseases, orthopedic procedures, neurological disorders, and degenerative conditions.

Resource Scarcity: Public banks face challenges in maintaining an adequate inventory of quality cord blood units. Limited participation among hospitals, stringent donation criteria, and handling issues result in many units being discarded. RAND researchers reported that public banks collect an average of 8,500 units each year but store only 5-40% of those collections (3). Additionally, the cost of a cord blood unit averages $40,000, making private banking a more attractive option for many families seeking peace of mind with a more suitably matched unit.

Future of public cord blood banking: To meet the increasing demand of UCB used in cell therapies, the field of cord blood banking is moving towards a model where public and private partnership is considered. This hybrid banking allows for storage of family-directed CB units, while those units are also getting human leukocyte antigen (HLA)-typed and included in the national stem cell donor registry. Thus, if the need arises, the HLA-compatible CB unit can be released to an unrelated recipient as a foreign donor stem cell graft. This model aims to increase the availability and diversity of cord blood units for public use by leveraging the resources and benefits of private storage.

Hybrid Banking Models: Hybrid banking is a general term for banking practices that combine elements of public and private storage. The common denominator is the aim to make otherwise privately stored UCB units available to the public, thus increasing the diversity and quantity of cord blood for donation. Different models of hybrid banking exist around the world. One of the common ones is the public–private integration. In this form of hybrid banking, the blood bank runs both a public and a private sector. The donated blood in the public sector is owned by the bank and can be used for allogeneic transplants as well as clinical trials and research. The privately stored cord blood belongs to the customer and can be used for his/her service only. Earnings from the private sector financially support the public storage. This form of hybrid banking is typically used to cope with funding shortfalls, which is particularly challenging when public banking is not supported by the government. Table 2 shows some of the private, public and hybrid cord blood banks available in the U.S. (please note, this is not an extensive list, other UCB banks in the U.S. may exist).

Interestingly, a recent prospective survey study conducted among postpartum women in Switzerland reported that 68% of the participants decided to have their UCB stored or donated. Among those women, 25% of them opted for hybrid storage, 72% of respondents stored UCB publicly, and 3% decided for private family-directed storage (4). This study highlights the potential of hybrid banking to expand the number of registered CB units available for transplantation.

The special interest group of cord blood highlights some of the recommendations provided by the American College of Obstetricians and Gynecologists (ACOG) concerning umbilical cord blood banking:

  • Cord blood collected from a neonate should not be used to treat genetic diseases or malignancies in that same individual.
  • Routine collection and storage of cord blood with private banks is not supported by current evidence.
  • Public banking is recommended for obtaining cord blood for transplantation, immune therapies, or other validated medical uses.
  • Obstetric care providers should be aware of state and local laws regarding cord blood banking, including those requiring physicians to inform patients about banking options.
  • Providers with financial interests in private cord blood banking must disclose these conflicts of interest.
  • When patients request information, balanced and accurate details about both public and private banking should be provided.
  • Various circumstances during labor and delivery may preclude adequate cord blood collection.
  • Collection should not compromise obstetric or neonatal care, nor should it alter routine practice of delayed umbilical cord clamping, except in rare cases of medical indications for directed donation.

Conclusion:

Since the first successful umbilical cord blood transplant in 1988, UCB has been used in children and adults for the correction of inborn errors of metabolism, hematopoietic malignancies, and genetic disorders of the blood and immune system, etc. The benefits and limitations of public versus private UCB banking should be reviewed with the patient because they serve different purposes. Hybrid UCB banking is a viable approach. Patients should be made aware of the quality control and regulatory organizations that provide oversight for the process of umbilical cord collection and storage. UCB collection should not compromise obstetric or neonatal care or alter routine practice

Table 2


Name

Type of Bank

City/State

AlphaCord

Private

Atlanta, GA

Americord

Private

New York, NY

Assure Immune

Private

Miami, FL

CariCord

Private

Aurora, CO

Cord Blood Registry

Private

San Bruno, CA

Cord Blood Solutions

Private

Montvale, NJ

Core23 BioBank

Private

Springfield, MO

Cryo-Cell International

Private

Oldsmar, FL

Cryopoint: Biorepository

Private

Brownsburg, IN

Evercord

Private

Seattle WA

Family Cord

Private

Los Angeles, CA

Family Link

Private

Louisville, KY

GeneCell International

Private

Doral, FL

Genecord

Private

Augusta, GA

LifebankUSA

Private

Cedar Knolls, NJ

Lifeforce Cryobanks (Cord for Life SM )

Private

Altamonte Springs, FL

MiracleCord

Private

Chicago, IL

New England Cord

Private

Marlborough, MA

PacifiCord

Private

Irvine, CA

Safetycord

Private

Montvale, NJ

Stembanc

Private

Chardon, OH

Stem Cell Cryobank

Private

Boynton Beach, FL

Stork Medical

Private

Montvale, NJ

Texas Stem Cell

Private

Houston, TX

ViaCord

Private

Waltham, MA

Xytex

Private

Augusta, GA

BloodworksNW

Public

Seattle, Washington

California's Umbilical Cord Blood Collection Program

Public

California, CA

Carolinas Cord Blood Bank

Public

Durham, NC

CHOC Cord Blood Bank

Public

Orange, CA

Cleveland Cord Blood Center

Public

Cleveland, Ohio

ClinImmune: University of Colorado Cord Blood Bank

Public

Aurora, CO

Gencure: Texas Cord Blood Bank

Public

San Antonio, TX

Gift of Life

Public

Boca Raton, FL

ITxM: The Institute For Transfusion Medicine

Public

Rosemont, IL

J.P. McCarthy Cord Stem Cell Bank

Public

Rochester Hills, MI

Life Line Stem Cell

Public

New Haven, IN

LifeCord Life South

Public

Gainesville, FL

MD Anderson Cord Blood Bank

Public

Houston, TX

Michigan Blood

Public

Grand Rapids, MI

New Jersey Cord Blood Bank

Public

Paramus, NJ

NY Blood Center: National Cord Blood

Public

Long Island City, NY

Oklahoma Blood Institute

Public

Oklahoma City, OK

San Diego Cord Blood Bank

Public

San Diego, CA

Saneron CCEL

Public

Tampa, FL

St. Louis Cord Blood Bank

Public

Park Avenue, St. Louis

StemCyte

Public

Baldwin Park, CA

University of Iowa Cord Blood Bank

Public

North Liberty, IA

Upstate Cord Blood Bank

Public

Syracuse, NY

Celebration Stem Cell Centre

Hybrid

Gilbert, AZ

CORD:USE

Hybrid

Orlando, FL

Core 23 BioBank

Hybrid

Springfield, Missouri

References

  1. Brunstein CG, Setubal DC, Wagner JE. Expanding the role of umbilical cord blood transplantation. Br J Haematol. 2007 Apr;137(1):20-35. doi: 10.1111/j.1365-2141.2007.06521.x. PMID: 17359369.
  2. National Cord Blood Inventory: Practices for Increasing Availability for Transplants and Related Challenges. GAO-12-23 - United States Government Accountability Office.
  3. Kapinos, Kandice A., Brian Briscombe, Tadeja Gracner, Aaron Strong, Christopher M. Whaley, Emily Hoch, Jakub P. Hlavka, Spencer R. Case, and Peggy G. Chen, Public Cord Blood Banks: Worthy of National Investment. Santa Monica, CA: RAND Corporation, 2017. https://www.rand.org/pubs/research_briefs/RB9977.html.
  4. Laue J, Ambühl J, Surbek D. Hybrid cord blood banking in a private-public-partnership: Women's perspectives. Transfusion. 2024 May 15. doi: 10.1111/trf.17858. Epub ahead of print. PMID: 38746954.


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